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ClinOleic 20% Emulsion · 1 trial · 1 indication
New nosocomial infections, defined as culture-proven infection including wound, drain, bloodstream, respiratory tract, and urinary tract infections during PN. The presence of nosocomial infections was diagnosed based on standardized Centers for Disease Control (CDC) guidelines for laboratory-confirmed bloodstream infection and did not distinguish catheter-related infections per se. The following daily information was evaluated by the study team for nosocomial infection surveillance: temperature (fever)curve, white blood cell counts, review of daily progress notes in the medical record, daily clinical microbiology laboratory culture data, orders for antimicrobial agents (agent, daily dose, and start/stop times will be recorded), review of all relevant dictated radiographic reports (e.g., chest radiographs, abdominal computer tomography), communication, as needed, with primary physicians and site infectious disease consultants, and use of the CDC guidelines.
| Arm | Type | Description |
|---|---|---|
| Intralipid 20% Intravenous Emulsion | ACTIVE_COMPARATOR | Subjects who require Total Parenteral Nutrition TPN receiving Intralipid 20% (soybean-based) |
| ClinOleic 20% Intravenous Emulsion | EXPERIMENTAL | Subjects who require Total Parenteral Nutrition TPN receiving ClinOleic 20% (olive oil based) |
| Name | Type | Description |
|---|---|---|
| ClinOleic 20% Intravenous Emulsion | DRUG | ClinOleic 20% is a lipid emulsion containing a mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%) corresponding to an essential fatty acid intake of approximately 20% of the total fatty acids intake. |
| Intralipid, 20% Intravenous Emulsion | DRUG | It is made up of 20% Soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection |
Inclusion criteria: * Age: 18 - 80 years when initiating PN * In medical/surgical ICU * Has central venous access to administer PN * Anticipated to receive PN ≥ 5 days Exclusion criteria: * Enrolled in an investigative study within the last 30 days prior to study entry * Female patients: pregnant...
ClinOleic 20% Emulsion is used for parenteral nutrition, providing essential fatty acids and calories to patients who cannot eat normally. It is an olive oil-based lipid emulsion being studied for use in intensive care unit (ICU) patients requiring total parenteral nutrition (TPN).
ClinOleic 20% Emulsion is developed by Baxter International Inc. (NYSE: BAX). The company is conducting clinical research to evaluate the emulsion's safety and efficacy in patients requiring parenteral nutrition.
ClinOleic 20% Emulsion is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial has been completed to assess its effects in ICU patients requiring total parenteral nutrition.
ClinOleic 20% Emulsion has one completed Phase 2 trial, NCT00672854, titled 'Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN.' This randomized, double-blind, active-controlled study enrolled 100 participants in the United States.
ClinOleic 20% Emulsion is an olive oil-based lipid emulsion. It is being compared against a soybean oil-based lipid emulsion in clinical trials to evaluate its use in parenteral nutrition for ICU patients.